Sigyn Therapeutics Expands Cardiovascular Disease Study to Target Lipoprotein Reduction

Sigyn Therapeutics, Inc. has announced plans to commence a multi-site clinical feasibility study of Sigyn Therapy™ in high-risk cardiovascular disease subjects, expanding its protocol to quantify lipoprotein reduction based on pre-clinical in vitro studies. Cardiovascular disease remains the number one cause of death globally according to the World Health Organization, making this research particularly significant for high-risk populations.

Sigyn Therapy™ represents a first-in-class whole-blood adsorption technology designed for use on dialysis machines located in hospitals and clinics worldwide. The technology simultaneously targets two critical factors in cardiovascular disease progression: inflammatory molecules that promote disease advancement and cholesterol-transporting lipoproteins that contribute to heart attacks, strokes, and other major adverse cardiovascular events. This dual-action approach could provide a comprehensive strategy for managing cardiovascular risk factors in vulnerable patient populations.

The study expansion builds upon the company's original protocol focusing on dialysis-dependent end-stage renal disease patients with endotoxemia and concurrent inflammation. These conditions significantly promote cardiovascular disease, which accounts for the majority of ESRD patient deaths. The successful completion of the feasibility study would establish the foundation for a pivotal efficacy study necessary to pursue potential market clearance through regulatory pathways.

Sigyn Therapy™ operates on a similar principle to lipoprotein apheresis, an established FDA-approved treatment that reduces lipoprotein(a) and low-density lipoprotein cholesterol from the bloodstream. Clinical studies of lipoprotein apheresis have demonstrated impressive 55% to 98% reductions in major adverse cardiovascular events among treated patients. However, treatment access remains severely limited in the United States, with fewer than 60 specialized apheresis centers available nationwide.

The potential advantage of Sigyn Therapy™ lies in its deployment capability on dialysis machines located in approximately 7,500 U.S. dialysis clinics, offering significantly broader treatment access. This technology can be conveniently administered to ESRD patients during their regularly scheduled dialysis treatments, eliminating the need for additional medical appointments or specialized facilities. The simultaneous targeting of multiple cardiovascular disease drivers introduces a broad-spectrum strategy that could potentially extend ESRD patient lives by addressing core disease mechanisms.

The economic implications are substantial, given that the U.S. dialysis industry generates approximately $34 billion in annual revenues from administering roughly 85 million treatments to more than 550,000 individuals with end-stage renal disease. Extending ESRD patient lives by just one month could increase industry revenues by approximately $2.8 billion annually, with primary beneficiaries being market leaders Fresenius Medical Care and Davita, Inc., who control 75% of the U.S. dialysis market. This study represents a significant step toward addressing the leading cause of mortality in a vulnerable patient population while potentially transforming cardiovascular disease management approaches.